COVID-19 Update

FDA Prioritizes Vaccine Approvals and Process Improvements; image: W.Scott McGill - stock.adobe.com

FDA Prioritizes Process Improvements

Better coordination in development and review of vaccines is needed.

Subunit Vaccines and the Fight Against COVID-19

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Meeting the Demand for Lipid Excipients

Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.

Application for COVID-19 Treatment Submitted to EMA

October 07, 2021

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals

October 07, 2021

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine

October 07, 2021

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

Merck and Ridgeback Biotherapeutics’ Oral Antiviral COVID-19 Treatment Reduces Risk of Hospitalization or Death by 50%

October 05, 2021

Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.

Getting a Nose for Vaccines

October 02, 2021

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

CHMP Performs Accelerated Assessment of Booster Dose of Spikevax

October 01, 2021

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.

REGEN-COV Shows Promising Results in Hospitalized COVID-19 Patients

October 01, 2021

Rengeron’s trial found that REGEN-COV significantly reduced viral load of patients with COVID-19.

Biden Hosts Global COVID-19 Summit

September 24, 2021

Biden outlines a plan to end the pandemic in a virtual global conference.

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

September 23, 2021

The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

Real-World Evidence Shows Strong Protection from COVID-19 with J&J Vaccine and Booster

September 23, 2021

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.